A Study to Evaluate the Effect of Recombinant Zoster Vaccine on New Diagnosis of Dementia in an Older Adult Population Aged 76 Years or Older in Finland

Официальное название

A Randomized, Placebo Controlled, Observer-blind, Phase IV Pragmatic Trial to Evaluate the Effect of Recombinant Zoster Vaccine (Shingrix) on Incident Dementia Diagnosis in an Older Adult Population Aged ≥76 Years in Finland

Обзор

The purpose of this study is to evaluate the effect of the recombinant zoster vaccine on the risk of new diagnosis of dementia among adults aged 76 years or older in Finland. Participants will be enrolled and randomized in a 3:1 ratio to receive either recombinant zoster vaccine or placebo.

Вмешательства

• Биопрепарат Recombinant zoster vaccine
  Recombinant zoster vaccine administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule.
• Препарат Placebo
  Placebo administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose).

Первичные конечные точки

• Hazard ratio of incident dementia diagnosis [Срок оценки: From first dose of study intervention (Day 1) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years]

Вторичные конечные точки (2)

• Hazard ratio of incident dementia diagnosis [Срок оценки: From 1 month after second dose of study intervention (2 to 6 months after first dose of study intervention) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years]
• Hazard ratio of incident Alzheimer's disease diagnosis [Срок оценки: From first dose of study intervention (Day 1) until the date of first Alzheimer's disease diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years]

Критерии участия

Критерии включения

• Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants.
• Age 76 years or older at the time of signing the informed consent.

Критерии исключения

• Prior receipt of a Herpes Zoster (HZ) vaccine.
• History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:

• History of a confirmed clinical diagnosis of dementia prior to enrolment.
• Prior or current use of medications intended to treat dementia.
• Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was conclusively ruled out); mild cognitive impairment on its own without any other information to indicate cognitive decline or dementia will not result in exclusion.
• Severely immunocompromised individuals.
• Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
• Living in a nursing facility.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Финляндия · 8 центров

• GSK Investigational Site — Espoo
• GSK Investigational Site — Helsinki
• GSK Investigational Site — Jarvenpaa
• GSK Investigational Site — Kokkola
• GSK Investigational Site — Oulu
• GSK Investigational Site — Seinäjoki
• GSK Investigational Site — Tampere
• GSK Investigational Site — Turku

Идентификаторы

NCT: NCT07502560 · 300889 · 2025-524598-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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